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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACCESS P2PSA CALIBRATOR ON THE ACCESS IMMUNOASSAY ANALYZER
Generic NameP2psa
ApplicantBeckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska, MN 55318
PMA NumberP090026
Supplement NumberS016
Date Received01/17/2017
Decision Date02/14/2017
Product Code OYA 
Advisory Committee Immunology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Add another filling line for the filling, sealing, and labeling of calibrator bottles using the new Bottle/Vial Filler.
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